FDA.reportPublic FDA data

200L - Leather Lead Gloves

Primary DI
G031200LRL0
Brand
200L - Leather Lead Gloves
Company
Shielding International Inc.
Model
200LRL
Device description
"Leather Lead glove - 15"" with foam liner - cold in pairs"
Published
2023-08-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IWPRadiographic Protective Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWPRadiographic Protective GloveRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G031200LRL0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiation-shielding procedure preparation glove/mittenA personal protective device intended to be used to shield the entire hand or hands of medical personnel from unnecessary exposure to primary and scattered radiation associated with the preparation of a diagnostic and/or therapeutic radiological procedure (e.g., patient positioning). It is typically intended for procedure set-up or patient positioning; it is not a patient examination/treatment glove, nor a surgical glove. It typically includes a thin layer of lead (Pb) or lead-equivalent material and may be fluid resistant.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
009647322
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G031VBO2XFNL0Vest Only w/ BeltVBO2XFNL2026-07-13
G031VBO2XFRL0Vest Only w/ BeltVBO2XFRL2026-07-13
G031VBO2XFRLL0Vest Only w/ BeltVBO2XFRLL2026-07-13
G031VBO2XFTL0Vest Only w/ BeltVBO2XFTL2026-07-13
G031VBO2XFTLL0Vest Only w/ BeltVBO2XFTLL2026-07-13
G031VBO2XMNL0Vest Only w/ BeltVBO2XMNL2026-07-13
G031VBO2XMNLL0Vest Only w/ BeltVBO2XMNLL2026-07-13
G031VBO2XMRL0Vest Only w/ BeltVBO2XMRL2026-07-13
G031VBO2XMRLL0Vest Only w/ BeltVBO2XMRLL2026-07-13
G031VBO2XMTL0Vest Only w/ BeltVBO2XMTL2026-07-13
G031VBO2XMTLL0Vest Only w/ BeltVBO2XMTLL2026-07-13
G031VBOLFNL0Vest Only w/ BeltVBOLFNL2026-07-13
G031VBOLFNLL0Vest Only w/ BeltVBOLFNLL2026-07-13
G031VBOLFRL0Vest Only w/ BeltVBOLFRL2026-07-13
G031VBOLFRLL0Vest Only w/ BeltVBOLFRLL2026-07-13
G031VBOLFTL0Vest Only w/ BeltVBOLFTL2026-07-13
G031VBOLFTLL0Vest Only w/ BeltVBOLFTLL2026-07-13
G031VBOLMNL0Vest Only w/ BeltVBOLMNL2026-07-13
G031VBOLMNLL0Vest Only w/ BeltVBOLMNLL2026-07-13
G031VBOLMRL0Vest Only w/ BeltVBOLMRL2026-07-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860010574508APFG65F&L Medical Products LLCIWP2023-11-28
00860010574522APFG75F&L Medical Products LLCIWP2023-11-28
00860010574553APFGXLF&L Medical Products LLCIWP2023-11-28
00860010574515APFG70F&L Medical Products LLCIWP2023-11-27
00860010574539APFG80F&L Medical Products LLCIWP2023-11-27
00860010574546APFG85F&L Medical Products LLCIWP2023-11-27
G031100VRL0Vinyl Lead GlovesShielding International Inc.IWP2023-08-08
G031101MITRL0Lead MittensShielding International Inc.IWP2023-08-08
G031101SLMITRL0Lead Slit MittensShielding International Inc.IWP2023-08-08
G031104OPMRL0Open Palm MittShielding International Inc.IWP2023-08-08
G031104VMRL0Vet MittShielding International Inc.IWP2023-08-08
08904333246673UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246680UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246697UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246703UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246710UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246727UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246734UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246741UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246758UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246765UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246772UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246789UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246796UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246802UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246819UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246826UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246833UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246840UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246857UniRayUNIRAY MEDICAL LLPIWP2023-02-11